CT­LA-4 bound for the clin­ic, Bris­tol-My­ers hands Cy­tomX $200M to kick off an ex­pand­ed dis­cov­ery pact

Sean Mc­Carthy, Cy­tomX CEO

Over the last three years, Bris­tol-My­ers Squibb has been steer­ing four pre­clin­i­cal dis­cov­ery pro­grams it part­nered on with South San Fran­cis­co-based Cy­tomX, mov­ing the lead CT­LA-4 an­ti­body to a near-term IND fil­ing with an eye on first-in-hu­man tri­als.

And now Bris­tol-My­ers is sign­ing up for eight more projects — six in on­col­o­gy and two more out­side of can­cer, as Cy­tomX push­es ahead in the clin­ic with a PD-L1 check­point the CEO be­lieves can blitz its way through a pack of ri­vals and in­to the spot­light.

Get­ting this deal done calls for a $200 mil­lion up­front, plus up to an ex­tra $3.6 bil­lion in mile­stones as well as roy­al­ties for any com­mer­cial­ized ther­a­py, bring­ing Bris­tol-My­ers’ in­vest­ment in­to Cy­tomX to $257 mil­lion in cash, with close to $5 bil­lion in goal mon­ey on the ta­ble.

For a dis­cov­ery deal, that’s a sub­stan­tial wa­ger. And in­vestors re­act­ed warm­ly to the news, dri­ving up shares by 24% Mon­day morn­ing.

“The work with Bris­tol-My­ers is go­ing very well,” says a pleased Cy­tomX $CT­MX CEO Sean Mc­Carthy.

The deal comes at a crit­i­cal time for Bris­tol-My­ers, as it wres­tles with set­backs for its PD-1 check­point drug Op­di­vo. And there are im­pli­ca­tions here for the fu­ture of Bris­tol-My­ers’ all-im­por­tant im­muno-on­col­o­gy fran­chise.

Cy­tomX’s claim to fame rests on its Pro­body an­ti­body plat­form. The com­pa­ny has de­signed an an­ti­body that links on to dis­eased cells, leav­ing healthy tis­sue alone, with ac­ti­va­tion in the tu­mor mi­croen­vi­ron­ment.

The biotech has its own PD-L1 check­point that just jumped in­to a Phase I/II study ear­ly this year. And its lead work with Bris­tol-My­ers could pro­vide a new and im­proved CT­LA-4 that is sup­posed to avoid the kind of off-tar­get tox­i­c­i­ty that has lim­it­ed Yer­voy’s use. That could at some point play a role in fu­ture Op­di­vo/Yer­voy com­bi­na­tions, like the one Bris­tol-My­ers is cur­rent­ly steer­ing in the clin­ic.

Cy­tomX has struck some mar­quee deals with a group of high-pro­file com­pa­nies, in­clud­ing Ab­b­Vie last year.

Mc­Carthy tells me he’s par­tic­u­lar­ly pumped by the idea that Bris­tol-My­ers’ $200 mil­lion will come in as com­plete­ly non-di­lu­tive rev­enue. The big biotech is pay­ing the freight on the new dis­cov­ery work, tak­ing no new eq­ui­ty in the deal and pro­vid­ing cash that can be in­vest­ed di­rect­ly in the com­pa­ny’s grow­ing pipeline.

That in-house ef­fort is led by a PD-L1 pro­gram that will look to emerge as a clear fa­vorite not on­ly to the ones al­ready on the mar­ket, but as well as the wave of fol­low-ups in the clin­ic at Pfiz­er/Mer­ck KGaA, As­traZeneca and more.

“We be­lieve the PD-L1 can be­come the cen­ter­piece of com­bi­na­tion im­nunother­a­pies mov­ing for­ward,” Mc­Carthy says.

That’s a bold state­ment, giv­en the hun­dreds of com­bi­na­tion ther­a­pies that are al­ready in the clin­ic as well as a long line­up of check­points that are un­der de­vel­op­ment. But Mc­Carthy says they have the pre­clin­i­cal da­ta need­ed to un­der­score the po­ten­tial. And he’s plan­ning to kick off a pair of com­bi­na­tion stud­ies with Yer­voy and Zelb­o­raf to demon­strate in re­al terms what he’s talk­ing about.

If he’s suc­cess­ful, there’s some ob­vi­ous up­side in this check­point fren­zied world we live in.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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